Risk Stratification of Patients Presenting With Upper Gastrointestinal Bleeding to the Emergency Department Using AIMS65 Score and Red Cell Distribution Width

NCT ID: NCT04825977

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 348 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-10-31

Brief Summary

The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.

Detailed Description

UGIB is a ticking time-bomb and emergency physicians are challenged to accurately assess risk, and aggressively manage patients with gastrointestinal bleeding within the stipulated time in the confines of emergency department. If not managed properly, it is associated with high mortality.

Various clinical prediction scores help in risk stratifying such patients. Among the scores, AIMS65 score is the easy to use score and has good mortality predictive accuracy. RDW, once thought as marker of chronic blood loss has recently been identified as a good prognostic indicator as well as good predictor of mortality in conditions where there is acute blood loss.

Both AIMS65 score and RDW value have been used separately as a predictor of morbidity and mortality in patients with UGIB. But there are not much studies so far evaluating their combined role as marker of predicting mortality as well as high risk among UGIB patients. Hence there is a need for a study to know the predictive value of combination of AIMS6S score and RDW in patients presenting to ED with symptoms of UGIB not been much studies comparing the relationship between RDW and upper GI bleed.

The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.

Conditions

Upper Gastrointestinal Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

RISK STRATIFICATION USING AIMS65 SCORE AND RDW

Risk Statification of patients presenting with upper gastrointestinal bleeding to the emergency department using AIMS65 score and Red cell Distribution Width.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. All patients presenting to ED with UGIB

2. Age more than 18 years of age

Exclusion Criteria

1. Patients not consenting to study

2. Patients with known hematological disorders

3. Patients in which endoscopy or blood transfusion is done outside

4. Patients in which RDW value and laboratory parameters required for AIMS65 score are not available.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jubilee Mission Medical College and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Dr.Vijay Chanchal A B

Junior Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siju V Abraham, MD

Role: STUDY_CHAIR

Jubilee Mission Medical College

Rajeev P C, MD

Role: STUDY_DIRECTOR

Jubilee Mission Medical College

Locations

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, India

Countries

India

Other Identifiers

CTRI/2019/03/018127

Identifier Type: REGISTRY

Identifier Source: secondary_id

35/18/IEC/JMMC&RI

Identifier Type: -

Identifier Source: org_study_id